Table of Contents
International Scholarly Research Notices
Volume 2014, Article ID 754695, 8 pages
http://dx.doi.org/10.1155/2014/754695
Research Article

Stability Indicating RP-HPLC Method for the Simultaneous Determination of Atorvastatin Calcium, Metformin Hydrochloride, and Glimepiride in Bulk and Combined Tablet Dosage Form

1Government Polytechnic for Women, Gujarathipeta, Srikakulam, Andhra Pradesh 532005, India
2Adept Pharma & Bioscience Excellence Private Limited, 10-3-561/3A/102, Vijayanagar colony, Hyderabad, Andhra Pradesh 500057, India

Received 19 March 2014; Revised 12 July 2014; Accepted 13 July 2014; Published 30 October 2014

Academic Editor: Hugh J. Byrne

Copyright © 2014 Devi Ramesh and Mohammad Habibuddin. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

A simple, rapid, and precise RP-HPLC method for simultaneous analysis of atorvastatin calcium, metformin hydrochloride, and glimepiride in bulk and its pharmaceutical formulations has been developed and validated. These drugs were separated by using Grace Smart Altima C-8 column (250 × 4.6 mm, 5-μm) with a mobile phase consisting of acetonitrile : phosphate buffer (60 : 40 (v/v), pH 3.0) at a flow rate of 1 mL/min, injection volume 25 µL, and detection at 235 nm. Metformin, atorvastatin, and glimepiride were eluted with retention times of 2.57 min, 7.06 min, and 9.39 min, respectively. The method was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with ICH (Q2B) guidelines. The results of all the validation parameters were found to be within the acceptable limits. The calibration plots were linear over the concentration ranges from 10 to 150 µg/mL, 20 to 200 µg/mL, and 10 to 150 µg/mL for atorvastatin, metformin, and glimepiride, respectively. The accuracy and precision were found to be between 98.2%–105% and ≤2% for three drugs. Developed method was successfully applied for the determination of the drugs in tablet dosage form and recovery was found to be >98% for three drugs. The degradation products produced as a result of stress studies did not interfere with drug peaks.